PMA P000008
- Device
- ReShape Lap-Band System
- Applicant
- Medtimo, Inc.
- PMA number
- P000008
- Supplement
- S047
- Product code
- LTI
- Decision date
- 2025-07-11
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- addition of a contract supplier, known as Needle Tech Products, for the Lap-Band System Access Port Needles
Current openFDA PMA Record#
- Device
- ReShape Lap-Band System
- Applicant
- Medtimo, Inc.
- PMA number
- P000008
- Supplement
- S051
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2025-07-11
- Decision code
- OK30
- Date received
- 2025-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of a contract supplier, known as Needle Tech Products, for the Lap-Band System Access Port Needles